TM-2023-017318 Exactech Hip Systems PMCF: A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Exactech
Summary
A Post-Market Domestic (US) and International Data Collection to Assess Exactech Hip Systems
Description
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive an Exactech Hip System for total hip arthroplasty (THA) prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Cohort 1: * Subjects who agree to participate in the study that have not had surgery prior to being enrolled in the study. * Skeletally mature (18 years of age or older). * The subject is willing and able to provide written informed consent for participation in the study. * Subject is to receive an Exactech Hip System THA for any approved indication for use. * The hip replacement will be performed by the investigator or a surgeon sub- investigator. * The devices will be used according to the approved indications. Cohort 2: * Subjects who agree to participate in the stud…
Interventions
- DeviceExactech Hip Systems
The Exactech Hip System comprises a fixed-bearing hip joint prostheses used in treating human hip joint diseases as part of THA. These prostheses include a combination of the components and are available in a range of sizes to accommodate varying anatomical requirements.
Location
- Tulsa Bone & Joint AssociatesTulsa, Oklahoma